WO2015183225A1

WO2015183225A1 - Position sensor-fitted and motorized, monoaxial unilateral bone fixator system

Info

Publication number: WO2015183225A1
Application number: PCT/TR2015/000232
Authority: WO
Inventors: Hacı KUTLU
Original assignee: Spi̇namer Sağlik Ürünleri̇ Sanayi̇ Ve Teknoloji̇ Li̇mi̇ted Şi̇rketi̇
Priority date: 2014-05-29
Filing date: 2015-05-25
Publication date: 2015-12-03
Also published as: TR201406039A2

Abstract

The invention particularly relates to a unilateral monoaxial external bone fixator, which reduces patient-related complications and provides remote data transfer throughout the treatment; performs extension-shortening operation with a motorized system that can be controlled automatically by the doctor, independent from the patient; fixing bone fragments and transmitting data about their positions by means of the units called sensor-fitted metaphysis clamp (1) and sliding clamp (2); and can perform correction by means of its ball-socket joints and correction module.

Description

DESCRIPTION

POSITION SENSOR-FITTED AND MOTORIZED, MONOAXIAL UNILATERAL BONE

FIXATOR SYSTEM

The Related Art

The invention relates to devices called unilateral monoaxial external fixators, which stably fix, fixate, extend, and shorten bone fragments via bone screws and wires.

The invention particularly relates to a unilateral monoaxial fixator system, which alleviates complications of a patient and provides remote data transfer during treatment; and which can be controlled automatically, independent from the patient, and/or by the doctor. The Prior Art

External fixator is a device which fixes bone fragments by means of bone screws or wires, in a stable way, until union is completed. Although studies on this subject had started in the midst of 19^th Century, the first significant external fixator example was provided by Lambotte in 1902.

The first fixator advanced versions of which is being used in the present day is the fixator developed by Hoffman in 1938. This configuration is followed by Wagner's unilateral fixator. Following these developments, successful results of the llizarov external fixator, which is a circular type fixator, enabled worldwide use of these methods and devices in clinics.

With the introduction of the dynamic axial fixator, which is a unilateral monoaxial fixator, in 1979 to the world by De Bastiani et a!., monoaxial fixators have started to be used more commonly around the world, and various improvements have been made on these configurations. Application Nos. US5320623, US5342360, US5437667, EP0695538B, EP0775468A1 , EP0955928B1 , EP1486174A2, US5601551 , US8388619 can be shown as examples for these improvements. In 1997, Dr. Haci Kutlu has introduced a modular dynamic axial fixator system, which he called Holyfix. In 2002 and 2003, the system was improved even more, and started to be used on a global scale. The advantages of the present invention with regard to above given improvements are as follows:

the system of the present invention is motorized,

it can be remote controlled via special software,

- information about bone positions can be obtained via remote access, by means of position sensors found on clamps, and

information can be obtained about the position losses and ultimate positions of the bones.

Circular fixators, which are different from unilateral monoaxial fixator systems, are also used with the purpose of bone extension and fixation. In the last decade, computer assisted manual and motorized circular fixators have also been disclosed. Application Nos. US 2002/0010465, EP1239784B1, EP2085037A1, EP2085038B1 , EP2417924A1 , US8333766 can be given as examples for these improvements.

Unilateral and monoaxial fixators are quite different systems than circular fixators; since they are less invasive then circular fixators, and they have lower risk of causing vein and nerve injuries. They are also more acceptable systems for patients. Therefore, monoaxial and unilateral bone fixator systems differentiate from circular fixators in terms of shape, function, and indication.

Similarly, significant problems are also encountered in the prior art monoaxial extension fixators, and practical and safe solutions can not be provided all the time. The most significant problem is the necessity of use of the manual fixators by the patient or the patient's relatives. Due to this necessity, the fixator can not be used as recommended, and accordingly, undesired complications may occur. And these complications are the complications, which can be controlled by design and technological improvements.

As a result, due to the above disclosed problems and the inadequacy of the prior art solutions, enhancement or improvement studies are required to be done in the related technical field for the purpose of developing a novel unilateral fixator, which reduces patient-related complications and provides remote data transfer, and which can be controlled by the doctor, independent from the patient. Purpose of the Invention

In the light of the prior art problems, the purpose of the invention is to develop a unilateral monoaxial fixator system in order to reduce patient-related complications and enable continuous monitoring and control during treatment via remote data transfer, and thus reduce additional complications.

Main purpose of the invention is to reduce patient-related complications and provide remote data transfer throughout the treatment. Therefore, a novel unilateral bone fixator is developed, which can be controlled automatically by the doctor and independent from the patient.

Another purpose of the invention is to enable a simple and secure extension and fixation operation.

Another purpose of the invention is to prevent extension complications caused by the patient via its remote access feature.

Another purpose of the invention is to achieve savings by means of reducing the number of repeating controls where the patient has to see the doctor.

Another purpose of the invention is to improve the quality of bone extension by means of enabling precise extension operations via several extensions to be made during the day in short intervals.

Another purpose of the invention is to be able to obtain remote data about the positions of bone fragments

Another purpose of the invention is to provide an MRI-compatible (Magnetic Resonance Imaging) embodiment.

Structural and characteristic features and the advantages of the invention will be comprehended more clearly with the accompanying figures and the detailed description written by references to these figures; and thus assessments should be done considering these figures and the detailed description. Figures for Better Understanding of the Invention

Figure 1: is the perspective view of the unilateral monoaxial fixator articulated model according to the present invention.

Figure 2: is the perspective view of the unilateral monoaxial fixator inarticulate extension model according to the present invention.

Figure 3: is the sensor-fitted clamp example of the unilateral monoaxial fixator according to the present invention.

Figure 4, is the perspective view of the motorized extension-shortening module used in the fixator embodiment according to the present invention.

Figure 4a, is the detailed and section view of the motorized extension-shortening module used in the fixator embodiment according to the present invention.

Figure 5, is the perspective view of the modular motorized extension-shortening module used in the fixator embodiment according to the present invention.

Figure 5a, is the detailed and section view of the modular motorized extension-shortening module used in the fixator embodiment according to the present invention.

Figure 5b, is the operation scheme of the motorized fixator embodiment according to the present invention via remote data transfer by means of a modular control unit, a

Smartphone, a computer and special software.

Figure 6: is the view of a remote controllable embodiment of the controlled motorized extension module, which can be used in an alternative embodiment of the fixator embodiment according to the present invention.

Figure 6a: is the detailed and section view of the remote controllable embodiment of the controlled motorized extension module, which can be used in an alternative embodiment of the fixator embodiment according to the present invention.

Figure 6b, is the operation scheme of the controlled motorized fixator embodiment according to the present invention via remote data transfer by means of a Smartphone, a computer and special software.

Figure 7, is the view of a remote controllable embodiment of the controlled modular motorized extension module, which can be used in an alternative embodiment of the fixator embodiment according to the present invention.

Figure 7a, is the detailed and section view of a remote controllable embodiment of the controlled modular motorized extension module, which can be used in an alternative embodiment of the fixator embodiment according to the present invention. DESCRIPTION OF PARTS REFERENCES

1. Sensor-fitted Metaphysls Clamp (Figure 3)

1.1. Position sensor

2. Sensor-fitted Sliding Clamp

3. Motorized extension-shortening module (Figure 4, 4a)

3.1. Power-transmitting reducer

3.2. Motor

3.3. Encoder

3.4. Data transfer-power socket

3.5. Bluetooth and/or wifi unit (optional)

3.6. Position sensor

3.7. Sealed box

3.8. External tube

3.9. Channels

3.10. Screwed shaft

3.11. Internal tube

3.12. Joint socket

3.13. Reverse grooved push rod slot

4. Joint

5. Sensor-fitted Half Sliding Clamp

6. Modular Motorized Extension-Shortening Module (Figure 5,5b) 6a. manual extension unit:

6a.1. External tube

6a.2. Channels

6a.3. Screwed shaft

6a.4. Rollers

6a.5. Internal tube (6a5.1 , 6a5.2: adaptor edge sockets)

6a.6. Allen slot (socket)

6b. modular motor unit:

6.1. Power-transmitting reducer 6.2. Motor

6.3. Encoder (electronic control unit)

6.4. Data transfer-power socket

6.5. Bluetooth and/or wifi unit

6.6. Position sensor

6.7. Sealed tube

7, Controlled Motorized extension-shortening module (Figure 6, 6a)

7.1. Power-transmitting reducer

7.2. Motor

7.3. Encoder

7.4. Rechargeable battery

7.5. Electronic control unit

7.6. Data transfer-charge socket

7.7. Manual on off button

7.8. Bluetooth and/or wifi unit

7.9. Position sensor

7.10. Sealed box

7.11. External tube

7.12. Channels

7.13. Screwed shaft

7.14. Internal tube

7.15. Joint socket

7.16. Reverse grooved push rod slot

8. Controlled Modular Motor unit (Figure 7, 7a)

8.1. Power-transmitting reducer

8.2. Motor

8.3. Encoder

8.4. Rechargeable battery

8.5. Electronic control unit

8.6. Data transfer-charge socket

8.7. Manual on off button

8.8. Bluetooth and/or wifi unit

8.9. Position sensor (optional)

8.10. Sealed box 9. Modular Control Unit (Figure 5b)

Electronic control unit

Rechargeable battery

Bluetooth-wifi unit

Fixator connection socket

Data transfer and charge socket

10. Smartphone (Figure 5b, Figure 6b)

11. Computer (Figure 5b, Figure 6b)

12. Software (Figure 5b, Figure 6b)

Drawings do not have to be scaled and details not necessary for comprehending the present invention may be neglected. Moreover, components which are at least widely equal or which have at least widely equal functions are shown with the same number.

DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the preferred embodiments of the bone extension and three- dimensional fixation fixator according to the invention are explained only for better understanding of the subject. While the motorized unilateral bone fixator of the invention is used in similar indications; it is also a unilateral-monoaxial fixator system providing novel solutions such as motorized automatic bone extension and shortening, and remote access. Moreover, the system has unique mechanical complementary modules. The unilateral fixator system according to the invention is formed of below given modules, in general terms:

Sensor-fitted Bone Clamps (1, 2, 5): are the units that hold bone fragments with the help of bone fixing screws. They are obtained by means of attaching position sensors (1.1) to the clamps of the system (Figure 3). In this way, they can be fixed at the bone clamps via remote access by means of the axial shifting position sensors found at the bone fragments (Figure 1 , Figure 2).

Joint (4): It is the joint used with the purpose of fixating bone fragments, and can be locked stably.

Motorized Extension-Shortening Module (3): It is the motorized extension - shortening module of the system. It is a sealed, closed system. It comprises a power-transmitting reducer (3.1) connected to the extension slot of the screwed shaft (3.10) found within the external tube (3.8); a motor (3.2) rotating the screwed shaft (3.10) via it is reducer; an electronic circuit/control unit (3.3) and sensors (3.6); and a power and data transfer socket (3.11 , 3.14) (Figure 4, Figure 4a).

Moreover, the system also comprises a modular control unit (9) consisting of an electronic control unit and a rechargeable battery.

Moduiar Control Unit (9): It is the rechargeable battery and the electronic control unit of the system. It can be connected to the motorized extension module (3) through cable and Bluetooth connections. Moreover, the module can be connected to computers and smartphones (10) through Bluetooth connection via its special software (12), and thus it can communicate with remote computers (11 ) or smartphones (10).

Modular Extension-Shortening Unit (6): It is an alternative embodiment of the motorized extension-shortening module (3): It is formed of two pieces:

L Manual Extension-Shortening Module (6a): It is formed of two interpenetrating tubes. At one end of the internal tube (6a.5), there are adaptor edge sockets (6a.5.1 and 6a.5.2) that are adapted to the joint or the metaphysis clamp. On the external tube (6a.1), there is a surface rubbed for the sliding clamp and transverse-positioned channels (6a.2) for eccentric screws (2.1) locating the clamp. The sliding clamp moves in a modular way and is fixed to the channels

(6a.2) thereon via eccentric screws (2.1). Extension and shortening screwed shafts (6a.3) are placed in the tubes. The screwed shaft (6a.3) is connected to the external tube (6a.1) via piston ring(s) and/or roller(s) (6a.4). The tubes are developed such that they would only provide precise extension and shortening, without rotating. When the shaft (6a.1) is rotated towards a direction with the extension key slot (6a.6) found at one end of the shaft (6a.3), the external tube (6a.1) moves over the internal tube (6a.2) and makes extension; and when it is rotated in the opposite direction, it makes shortening (Figures 5, 5a).

/. Modular Motor Unit (6b): An electric motor (6.2), a reducer (6.1), an encoder (6.3), a data-power transmission socket (6.4), a Bluetooth-wifi (optional) module (6.5), and a position sensor (6.6) (optional) are mounted in a sealed modular box (6.7) (Figure 10b). Modular motor unit can be adapted to the manual extension module. The amount and time of extension and shortening, and the speed of the motor can be adjusted by the doctor in front of the patient, through the control panel connected to the data transfer socket (6.4).

Controlled Motorized Extension-Shortening Module (7): It is an alternative embodiment of the motorized extension-shortening module (3) of the system, and it facilitates remote access. The unit consists of two closed telescopic sealed tubes. It comprises a power-transmitting reducer (7.1) connected to the extension slot of the screwed shaft (7.13) found within the external tube (7.11); a motor (7.2) rotating the screwed shaft (7.14) via it is reducer; an electronic circuit/control unit (7.3) and a rechargeable battery (7.4); a power and data transfer socket (7.6), an on off button (7.7), a wireless communication module: Bluetooth-wifi (7.8), and a position sensor (7.9) (optional) (Figure 6, Figure 6a, Figure 6b).

Controlled Modular Motor Unit (8): It is obtained by addition of remote control and data transfer option to the modular motor unit (6b). The system prepared for operating the fixator is operated via special software (12). With this purpose, units (8.8) with Bluetooth and/or wifi connection are present on this unit. A manual on off button (8.7) found thereon can be used by the patient in emergency situations (Figure 7, Figure 7a).

Smartphone (10): It is a Software-installed (Fixator operating system) (12) mobile phone.

Computer (11): It is a Software-installed (Fixator operating system) (12) PC. Operations can be made via direct or remote connection with the fixator.

Software (Fixator operating system) (12): It is the operation software of the fixator.

It is a fixator operating system prepared for PCs and/or smartphones (android) and it allows:

· Remote control of the motor unit, • Operating the motor back-and-forth and stopping the motor,

• Adjusting the speed and operating time of the motor,

• Data transfer for device situation, position, and other commands,

• Recording and storing data, and

• Providing printed and electronic output.

The system can perform its function by means of following below given operation steps:

• Bone is fixed with the help of bone screws by using bone screw channels at the clamps (1 , 2, 5).

• Afterwards, if extension is required, bone osteotomy is performed.

• If needed, fixation is performed by using the joint (4).

• If extension is desired only, automatic extension or shortening operation is started via direct or remote access to the motor unit (3, 6, 7, 8).

• Or, the protocol of other options is carried out.

• The operation is monitored by periodic direct or remote controls. Report is obtained about the extension amount and situation, and operating protocol can be changed, if required. In other words, the amount, speed, and time of extension or shortening can be adjusted.

• Report can be obtained about clamp positions, or in other words, bone fragment positions, by means of the sensors found on the clamps of the device.

• In case a problem occurs about operation and protocol of the system, the system sends a warning to the user and the doctor.

• The user and the doctor can intervene in the device, in case of an emergency.

Claims

1. A unilateral monoaxiai external bone fixator, which unilaterally and monoaxially fixes bone fragments from outside by means of units called clamps, with the help of bone screws; and which can perform extension or shortening on bones by means of an extension module, in the field of orthopaedics and traumatology; characterized in comprising a motorized extension-shortening module (3) which can perform automatic extension-shortening on bones.

2. The fixator according to Claim 1 , characterized in that; said motorized extension-shortening module (3) comprises:

- two interpenetrating tubes consisting of an external tube (3.8) and an internal tube (3.11);

- a joint socket (3.12) compatible with the joints (4) and clamps (1) of the system;

- at least one screwed shaft (3.10) found within the external tube (3.8) and moving the two tubes among each other without rotation;

- a power-transmitting reducer (3.1 ) moving this screwed shaft (3.10);

- piston ring(s)-roller(s) (3.4) connecting the screwed shaft (3.10) with the externa! tube (3.8);

- a motor (3.2) rotating the screwed shaft (3.10) by means of the reducer (3.1);

- an encoder (3.3) enabling control of the motor (3.2);

- a charge and data transfer-power socket (3.4);

- a modular control unit (9) consisting of a rechargeable battery, an electronic circuit and a control panel, and connected to the motorized extension- shortening module (3) via cabled/wireless connection; and

- software (12) operating the system.

3. The fixator according to Claim 1 , characterized in that; said motorized extension- shortening module (3) comprises a position sensor (3.6).

4. The fixator according to Claim 1 , characterized in that; said motorized extension- shortening module (3) comprises a Bluetooth and/or wifi unit (3.5).

5. The fixator according to Claim 1 , characterized in that; the motorized extension- shortening module (3) is a modular motorized extension-shortening module (6) comprising a modular motor unit (6b) and a manual extension unit (6a), which are mountable/demountable among each other.

6. The fixator according to Claim 5, characterized in comprising a manual extension unit (6a), which comprises:

two interpenetrating tubes consisting of an external tube (6a.1) and an internal tube (6a.5);

at least one screwed shaft (6a.3) found within the external tube (6a.1) and moving the two tubes among each other without rotation;

piston ring(s)-roller(s) (6a.4) connecting the screwed shaft (6a.3) with the externa! tube (6a.1);

a key slot (6a.6) at the outward end of the screwed shaft (6a3); an external end of the internal tube (6a.5) having differences for joint and clamp adaptations;

and a modular motor unit (6b) sealed tube (6.7) which can be mounted to the manual extension unit (6a), and which comprises:

a reducer (6.1), a motor (6.2), an encoder (6.3), and a data transfer- power socket (6.4).

7. The fixator according to Claim 6, characterized in that; the modular motorized extension-shortening module (6) can be connected to the modular control unit (9) via cabled/wireless connection.

8. The fixator according to Claim 1 or 5, characterized in that; the modular control unit (9) comprises:

- an electronic control unit

- a rechargeable battery

- a fixator connection socket

- a data transfer and charge socket

- a data transfer kit providing wireless connection and data transfer; and

- software (12) enabling communication with smartphones (10) and computers (1 1).

9. The fixator according to Claim 1 , characterized in that; the motorized extension- shortening module (3) is a controlled modular extension-shortening unit (7), which comprises a modular control unit (9) integrated to the motorized extension-shortening module (3) in a monoblock structure; which enables communication of the fixator with smartphones (10) and computers (1 1); and which allows direct and remote control of the fixator.

10. The fixator according to Claim 9, characterized in that; said controlled modular extension-shortening unit (7) comprises: a screwed shaft (7.13) moving two interpenetrating tubes within each other without rotation; piston ring(s)-roller(s) connecting this screwed shaft (7.13) with the external tube; a reducer (7.1) moving the screwed shaft (7.13) and providing power transmission; a motor (7.2) moving the reducer; an encoder (7.3) controlling the motor; a rechargeable battery (7.4); an electronic control unit (7.5); a data transfer and charge socket (7.6); a manual on off button (7.7); a Bluetooth and/or wifi unit (7.8); a sealed box (7.10); and software (12).

11. The fixator according to Claim 10, characterized in that; said controlled modular extension-shortening unit (7) comprises a position sensor (7.9).

12. The fixator according to Claim 9, characterized in that; the controlled modular extension-shortening unit (7) does not comprise wireless communication units and it comprises a control panel enabling direct control of the fixator in front of the patient.

13. The fixator according to Claim 5, characterized in that; said fixator comprises a modular control unit (9) integrated into the modular motor unit (6b), and said modular motor unit (6b) mounted into a sealed box (6.7) comprises:

- an electric motor (6.2);

- a reducer (6.1);

- an encoder (6.3);

- a data transfer-power socket (6.4);

- a Bluetooth and/or wifi sensor unit (6.5); and

- system software (12) enabling communication of the fixator with smartphones (10) and computers (11).

14. The fixator according to Claim 5, characterized in that; said fixator comprises modular control unit (9) enabling control operation by the doctor through the control panel in front of the patient, and providing cabled/wireless connection with the modular unit (6b).

15. The bone fixator according to Claim 1 , characterized in that; the sensor-fitted metaphysis clamp (1), the sensor-fitted sliding clamp (2), and the sensor-fitted half sliding clamp (5) comprises position sensors (1.1) enabling fixing of bone fragment positions via direct and remote access.